Individualisation of Voriconazole Antifungal Therapy Antifungal Therapy (PIVOTAL)
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|ClinicalTrials.gov Identifier: NCT01887457|
Recruitment Status : Suspended (Transfer of management of study)
First Posted : June 26, 2013
Last Update Posted : October 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Immunocompromised Patient Aspergillosis Fusarium||Drug: VFEND||Phase 2|
Invasive fungal infections are a major cause of morbidity and mortality in patients with haematological malignancy and haematopoietic stem cell transplantation.
Voriconazole is routinely used as a first-line agent for the treatment of invasive aspergillosis, invasive fusariosis and scedosporiosis. Voriconazole has extreme pharmacokinetic variability. Adult patients with a trough concentration of < 1 mg/L have a lower probability of clinical response whereas patients with trough concentrations > 6 mg/L a higher probability of toxicity.
Therapeutic drug monitoring for dose adjustment is advocated but there are no algorithms that enable voriconazole dosage to be reliably adjusted to achieve desired trough concentrations in a timely and optimally precise manner.
Novel ways to deliver optimised antifungal therapy are urgently required and this trial will evaluate whether giving a patients a tailored dose of voriconazole is safe and effective.
Plasma concentrations will be taken in real time and inputted in dose software that will calculate an optimum dose for the required trough concentration of 1-3 mg/L.
The software has been developed using data from phase I and III trials of voriconazole.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PIVOTAL: Pharmacological Individualisation of VOriconazole Therapy for AntifungaL Treatment|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||December 2016|
Standard adult Voriconazole (VFEND) Loading (1 hr infusion): 6mg/kg at 1 hour and 12 hours on day 1. Followed by standard maintenance dose 4mg/kg at 1 hour and 12 hours on day 2 (1 hour infusion). Day 3 follows the same schedule, expect the dose is adjusted, this dose is used on Day 4 and a further dose adjustment is made that is administered as above on Day 5.
voriconazole will be administered in iv form
Other Name: voriconazole
- Dose adjustment success [ Time Frame: Day 5 of treatment ]Dose adjustment success will be evaluated by plasma trough concentration on day 5, successful dose adjustment is defined as a trough concentration of 1-3 mg/L of voriconazole.
- Mortality of patients [ Time Frame: 35 Day after starting treatment ]To examine the mortality of patients receiving individualised voriconazole dosing
- Toxicity [ Time Frame: Day 5 of treatment and 35 day follow-up ]To evaluate the adverse events that are attributable to voriconazole as assessed by CTCAE v4.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01887457
|The Christie NHS Foundation Trust|
|Manchester, United Kingdom, M20 4BX|
|Study Chair:||William Hope||University of Liverpool|